Antidepressants increased the risk compared to placebo of suicidal thinking
and behavior (suicidality) in children, adolescents, and young adults in short
term studies of major depressive disorder (MDD) and other psychiatric disorders.
Anyone considering the use of nortriptyline hydrochloride or any other antidepressant
in a child, adolescent or young adult must balance this risk with the clinical
need. Short term studies did not show an increase in the risk of suicidality
with antidepressants compared to placebo in adults aged 65 an older. Depression
and certain other psychiatric disorders are themselves associated with increases
in the risk of suicide. Patients of all ages who are started on therapy should
be monitored appropriately and observed closely for clinical worsening, suicidality,
or unusual changes in behavior. Families and caregivers should be advised
of the need for close observation and communication with the prescriber. Nortriptyline
hydrochloride is not approved for use in pediatric patients. (See WARNINGS:
Clinical Worsening and Suicide Risk, PRECAUTIONS: INFORMATION
FOR PATIENTS, and PRECAUTIONS:
Pediatric Use)